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COVID-19: FDA Revises Treatment EUAs, Issues Fraud Warning

The Food and Drug Administration (FDA) recently revised two emergency use authorizations (EUA) granted for COVID-19 treatments.

FDA and the Department of Health and Human Services Assistant Secretary for Preparedness and Response announced May 20 an extension to the shelf life for specific lots of bebtelovimab, a refrigerated monoclonal antibody treatment developed by Eli Lilly.

The treatment, authorized in February to treat mild to moderate COVID-19 in those with high risk of progressing to severe disease, originally had a 12-month shelf life. After review of additional Eli Lilly data, FDA determined select lots now may be stored for an additional six months after their expiration date, at 2°C to 8°C (36°F to 46°F), in the original carton to protect from light. FDA has updated its bebtelovimab fact sheet for health care providers to reflect this change.

FDA on May 17 revised the scope of authorization for Evusheld, an AstraZeneca product comprising the monoclonal antibody tixagevimab co-packaged and administered with cilgavimab, to reflect new information on hypersensitivity reactions and the risk of cross-hypersensitivity with COVID-19 vaccines.

In December 2021, FDA authorized Evusheld for pre-exposure prevention in immunocompromised individuals and revised the initial dose in February 2022. The revised authorization urges clinicians to consult an allergist-immunologist before administering Evusheld to individuals with a history of a severe allergic reaction, such as anaphylaxis, to a COVID-19 vaccine. All individuals who receive Evusheld should be treated by a health care provider with the appropriate medical capacity to manage severe allergic reactions and be observed for at least one hour after injection to monitor for hypersensitivity reactions.

Additionally, FDA issued a warning to Santhigram Kerala Ayurvedic Co. of U.S., Inc., for selling unapproved products with fraudulent claims to treat multiple diseases, including COVID-19. These include the company’s “Smokers Kit/Respiratory Care Kit” and “Immunocare Kit.” FDA warned that failure to address this warning could result in legal action and requested the company notify FDA in writing within 15 days how it plans to rectify these violations.

Visit the America’s Essential Hospitals coronavirus resource page for more information about the pandemic.

Contact Senior Director of Policy Erin O’Malley at eomalley@essentialhospitals.org or 202.585.0127 with questions.

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About the Author

Emily Schweich is a communications manager at America's Essential Hospitals.

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